21 CFR 884.1630 — Colposcope (And Colpomicroscope)
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1630
Identification
A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
Classification Rationale
Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | 2 | 56 | 3rd Party |
| MOK | Vaginoscope And Accessories | 2 | 2 | 3rd Party |
| OHE | Forensic Evidence Sexual Assault Kit | 2 | 0 | |
| PTZ | Colposcope (And Colpomicroscope), Exempt | 2 | 0 | SaMD |
Special Controls
HEX — Colposcope (And Colpomicroscope)
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
MOK — Vaginoscope And Accessories
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
OHE — Forensic Evidence Sexual Assault Kit
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
PTZ — Colposcope (And Colpomicroscope), Exempt
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
